[99mTc]Tc-DB8 Accumulation in Primary Tumor in Breast Cancer With Positive and Negative Estrogen Receptor Expression

Description:

The study should evaluate the \[99mTc\]Tc-DB8 accumulation in primary tumour of breast cancer patients with positive and negative estrogen receptor expression.

Sponsor:

Tomsk National Research Medical Center of the Russian Academy of Sciences

Phase:

Phase 2

Contacts:

Vladimir I Chernov, MD, Prof (PRINCIPAL_INVESTIGATOR)

DB8

Isotope(s):
Target(s):
  • GRPR
Ligand Class: Peptides
Inclusion
  • White blood cell count: \> 2.0 x 109/L
  • 1. Subject is \> 18 years of age
  • Hemoglobin: \> 80 g/L
  • Hematological, liver and renal function test results within the following limits:
  • Availability of results from estrogen receptor status by Immunohistochemistry previously determined on material from the primary tumor
Exclusion
  • Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C
  • Second, non-breast malignancy
  • 1. Any system therapy (chemo-/targeted therapy)
  • Administration of other investigational medicinal product within 30 days of screening
  • Active current autoimmune disease or history of autoimmune disease